A letter from the U.S. pharmaceutical association (PhRMA) to the TTIP chief negotiator for the United States, Douglas Bell, states: "The disclosure of confidential data from clinical and pre-clinical study files and patient data puts at risk the health system and the well-being of patients." Why more transparency should harm the health systems, the lobby group doesn't explain, but it makes clear to the negotiator how he should conduct the negotiations with the EU: the publication of commercially-sensitive data from a market authorization, the PhRMA letter said threateningly, is not only contrary to the rules of the American FDA, but also to the internationally-accepted intellectual property rights of the World Trade Organization, the so-called TRIPS Agreement. "PhRMA and its members call on the U.S. government to influence the EU at all levels in order to eliminate this problem."

What's worrying is that there's already been one attempt to water down these requirements. Der Tagesspiegel suggests this may have been as a result of pressure from the European Commission, concerned about US reaction to them. It will be interesting to see how the Commission reconciles any US demands during the TAFTA/TTIP negotiations to remove the requirement to publish drug safety information with the new EU regulation that requires it.